A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)

Phase 1

• Conditions: Moderately to severely active Rheumatoid Arthritis; MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2019-004369-42-DE
• Lead Sponsor: Fresenius Kabi SwissBioSim GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-27
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 542

Inclusion Criteria

1. Are =18 years of age.
2. Diagnosis of rheumatoid arthritis according to the revised 1987 ACR/EULAR Classification 2010 criteria with disease duration of =6 months.
3. Have moderately to severely active rheumatoid arthritis as defined by:
a.Swollen Joint Count =6 (66 joint count) and Tender Joint Count =6 (68 joint count)
4. Must have been treated with methotrexate for at least 12 consecutive weeks immediately prior to randomization and are on a stable dose between 10 and 25 mg/week methotrexate for the last 8 weeks prior to screening.
5. Have had previous inadequate clinical response to at least one modifying anti rheumatic drug.
6. Women of childbearing potential (i.e., considered fertile following menarche and until becoming postmenopausal unless permanently sterile) can participate only if they have a negative serum pregnancy test at screening and a negative urine pregnancy test at Day -1 before randomization. Women of childbearing potential must have used and agree to use a highly effective contraception (i.e., methods with a failure rate of less than 1% per year), for 4 weeks before randomization and must agree to continue to practice adequate contraception for 3 months after the last study drug administration.
Note: A separate ICF will be provided to and signed by each patient to provide information on the general risks of study participation related to COVID-19 and to document that it is understood by the patient. Another separate Informed Consent Form will be required to be understood and signed by partners of male participating patients who become pregnant during the study or within 10 weeks after the participating patient’s last dose of study drug.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 298
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 244

Exclusion Criteria

1. American College of Rheumatology functional class IV as defined by the ACR classification of functional status or wheelchair/bedbound.
2. Previously received tocilizumab, an investigational or licensed biosimilar of tocilizumab or any interleukin-6 acting drugs.
3. Prior use of targeted synthetic disease-modifying anti-rheumatic drugs like janus kinase inhibitors.
4. Prior use of more than two biologic treatments for rheumatoid arthritis.
5. Received a live or attenuated vaccine within 4 weeks prior to randomization.
6. Patient is considered by the PI, for any reason, to be an unsuitable candidate for the study.
7. Has a serious and/or unstable and/or poorly controlled medical condition or other relevant medical condition or a history of clinically significant disease or any other condition that, in the opinion of the Investigator, would put the patient at risk by participation in the study.
8. Confirmed or, based on the signs and symptoms observed at the time of assessment, suspected active COVID-19 infection at the time of screening and/or randomization.
9. Has had any infection as follows:
a. Herpes zoster or any opportunistic invasive infection within 6 months of screening.
b. Frequent chronic or recurrent infections.
c. A positive test for human immunodeficiency virus subtype 1 or 2, hepatitis C antibody, hepatitis B surface antigen and/or core antibody for IgG and/or IgM or total Ig at screening.
d. A serious infection within 8 weeks prior to randomization.
e. Required treatment with oral antibiotics and/or anti-fungal drugs within 14 days prior to randomization.
10. Medical evidence of active or latent tuberculosis or has had active or latent tuberculosis disease at any time in the past.
11. History of clinically significant drug or alcohol abuse within the last year prior to randomization.
12. Laboratory abnormalities that were considered clinically significant by the Investigator OR any of the following at screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified